基于研制现场核查探讨体外诊断试剂产品技术要求对于设计开发的作用  

On the Functions of Technical Requirements in Design and Development Under the On-site Inspection of In Vitro Diagnostic Reagent Product Development

作　　者：李丽莉[1] 温晶 郭准 李颖 杨振[1] 曲守方[1] Li Lili;Wen Jing;Guo Zhun;Li Ying;Yang Zhen;Qu Shoufang(National Institutes for Food and Drug Control,Beijing 100050,China;Center for Food and Drug Inspection of NMPA,Beijing 100044,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]国家药品监督管理总局食品药品审核查验中心,北京100044

出　　处：《中国药事》2021年第5期523-529,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:探讨技术要求对于设计开发的作用,为诊断试剂新产品研发提供借鉴。方法:梳理相关法规,结合研制现场核查经验,对产品技术要求关键要素在设计开发策划、输入、输出及转换、验证和确认、变更等过程中的作用进行分析,剖析核查关注点。结果与结论:技术要求在设计开发的作用,一方面是产品的技术核心,另一方面是连接设计开发各环节的纽带。诊断试剂设计开发过程是"产、学、研、检"合作产业化的关键,发挥技术要求作用,强化设计开发过程的规范性,能够提高设计开发水平,必将有力促进具有自主知识产权高端检测技术成果的转化与产业化。Objective: To explore the functions of technical requirements in design and development, and to provide references for the development of new diagnostic reagent products. Methods: Under the relevant laws and regulations, combined with the experience of on-site inspection, the functions of key elements of product technical requirements in the process of design and development planning, input, output, conversion, verification and confirmation and modification were analyzed, and the focus of verification was dissected. Results and Conclusion: The functions of technical requirements in design and development lie in the technical core of products on the one hand, and the other lies in the link connecting all links of design and development. The design and development process of diagnostic reagents is the key to the cooperative industrialization of "production, learning, research and inspection". The of technical requirements and the standardization of the design and development process will improve the level of design and development and forcefully promote the transformation and industrialization of high-end testing technology with independent intellectual property rights.

关 键 词：研制现场核查 诊断试剂 产品技术要求 设计开发 规范性 质量管理体系 

分 类 号：R95[医药卫生—药学]